Remote Bioanalysis Strategy Lead – PK & Biomarkers

Otsuka America Pharmaceutical Inc.; Atlanta (GA); Remote; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) match with company contribution

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Associate Director, Bioanalysis to provide strategic and scientific oversight of outsourced bioanalytical activities supporting clinical development, with a primary focus on pharmacokinetics (PK) and biomarkers.

The role requires deep expertise in LC-MS/MS, ligand-binding assays, and cell-based methods, along with a strong understanding of global bioanalytical regulatory requirements.

Qualifications

• Ph.D. with 5+ years in regulated bioanalysis or MS/BS with 8+ years in the field.
• Expertise in PK and biomarker assays for clinical development.
• Strong knowledge of global regulatory bioanalytical guidance.
• Hands-on experience with LC-MS/MS, ELISA, ECL, flow cytometry.
• Experience managing CROs and external partnerships.

Responsibilities

• Provide strategic scientific leadership for outsourced bioanalytical activities.
• Oversee method development, qualification, validation, and data analysis.
• Manage CRO partnerships, vendor performance, budgets, and timelines.
• Ensure study data are audit-ready and regulatory compliant.
• Assess new technologies and drive continuous improvement.

Skills

Regulated bioanalysis

Pharmacokinetics (PK)

Mass spectrometry

LBA assays

Immunogenicity assays

CRO management

Project management

Communication skills

Education

PhD in bioanalytical science

MS/BS with 8+ years experience

Tools

LC-MS/MS

ELISA

ECL

Flow cytometry

Job description

Otsuka America Pharmaceutical Inc. is seeking an Associate Director, Bioanalysis to provide strategic and scientific oversight of outsourced bioanalytical activities supporting clinical development, with a primary focus on pharmacokinetics (PK) and biomarkers.

The role requires deep expertise in LC-MS/MS, ligand-binding assays, and cell-based methods, along with a strong understanding of global bioanalytical regulatory requirements.